Primary liver cancer with high-risk recurrence factors
Conditions
Interventions
experimental group:Treat with HAIC
control group:Treat with TACE
Sponsors
Eastern Hepatobiliary Surgery Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-70 years, no restrictions on gender, ethnicity, region, etc.; 2.ECOG stamina score 0-1 points, Child-Pugh grade A~B; 3.Underwent radical resection of liver cancer, and the postoperative pathological diagnosis was HCC; 4.There are high risk factors for recurrence: single lesion, diameter > 5 cm, or diameter 3-5 cm, MVI = M1/M2, or diameter < 3 cm, MVI = M2; multiple lesions 2-3; accompanied by portal vein tumor thrombus ( PVTT) (Chengs classification type I: tumor thrombus involving the portal vein segment and above, type II: tumor thrombus involving the right/left portal vein); 5.No evidence of recurrence or metastasis was found in the preoperative examination; 6.Subjects have informed consent, understand and are willing to cooperate with the trial protocol, and sign relevant documents.
Exclusion criteria
Exclusion criteria: 1.Patients with other malignant tumors within the past 3 years or at the same time; 2.Have uncontrolled high blood pressure or clinical symptoms or diseases of the heart: (1)Heart failure above grade 2, unstable angina; (2)Myocardial infarction occurred within 1 year; (3)Supraventricular or ventricular arrhythmia with clinical significance requires treatment or intervention; 3.Poor postoperative recovery, single organ or multiple organ failure. 4.Patients with contraindications to TACE or HAIC treatment, active clinically severe infections (> Grade 2 NCI-CTCAE version 5.0), except for HBV and HCV infections; significant clinically significant bleeding symptoms or symptoms have occurred within 3 months before randomization Clear bleeding tendency; 5.Known genetic or acquired bleeding and thrombotic tendency (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence-free survival RFS;Survival rate;Adverse Event, AE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lifetime;recurrence-free survival rate; | — |
Countries
China
Contacts
Public ContactZhai Jian; Wang Kui
Eastern Hepatobiliary Surgery Hospital
Outcome results
None listed